Remote Design Quality Engineer for Medical Device Transfers

GForce Life Sciences; Memphis (TN); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k

Job summary

GForce Life Sciences is seeking a Consultant, Design Quality Engineer to support a critical manufacturing and product transfer initiative for a medical devices client. The role focuses on updating Device Master Records and related quality documentation to reflect site-specific processes, including inspection, packaging and labeling.

Ideal candidates have about 2+ years in medical device quality, with direct industry experience and knowledge of PFMEAs, DMRs, ISO 13485 and ISO 14971.

Qualifications

• 2+ years in medical device quality, design quality or manufacturing quality.
• Direct medical device industry experience.
• Knowledge of Device Master Records (DMRs) and content.
• Understanding of manufacturing process flows, PFMEAs, and risk docs.
• Familiarity with ISO 13485 and ISO 14971.
• Experience with quality docs, processes or transfers.

Responsibilities

• Review DMRs and update documentation for transfer.
• Update DMRs to reflect new processes, equipment, inspection, packaging, and labeling.
• Review process flows to align with DMRs.
• Support PFMEA review and updates for new facility.
• Evaluate risk management docs for transferred processes.
• Ensure docs meet ISO 13485/14971.
• Identify gaps between docs and implemented processes.
• Collaborate with cross-functional teams to resolve discrepancies.
• Manage deliverables and communicate status.
• Apply transfer methodology across product lines and SKUs.

Skills

Medical device quality experience

PFMEA

Documentation review

Cross-functional collaboration

Tools

ISO 13485 knowledge

ISO 14971 knowledge

Job description

GForce Life Sciences is seeking a Consultant, Design Quality Engineer to support a critical manufacturing and product transfer initiative for a medical devices client. The role focuses on updating Device Master Records and related quality documentation to reflect site-specific processes, including inspection, packaging and labeling.

Ideal candidates have about 2+ years in medical device quality, with direct industry experience and knowledge of PFMEAs, DMRs, ISO 13485 and ISO 14971.